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Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC (BRISK TA)

This study is currently recruiting participants.
Verified February 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00908752
First received: May 22, 2009
Last updated: June 18, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.


Condition Intervention Phase
Hepatocellular Carcinoma
 Drug: Brivanib
Drug: Brivanib Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy [ Time Frame: Survival will be assessed continuously ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms [ Time Frame: End of Study ] [ Designated as safety issue: No ]
  • To evaluate the safety of brivanib in combination with TACE [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 870
Study Start Date: February 1920
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brivanib Drug: Brivanib
Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664
Placebo Comparator: Brivanib Placebo Drug: Brivanib Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diagnosis of hepatocellular carcinoma
  • Cirrhotic status of Child-Pugh Class A or B with a score of 7
  • ECOG performance status of 0 or 1
  • Adequate hematologic, hepatic, and renal function

Exclusion criteria:

  • Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
  • History of cardiac disease
  • Active and untreated hepatitis B
  • Inability to swallow tablets or untreated malabsorption syndrome
  • History of human immunodeficiency virus (HIV) infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908752

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Show 105 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00908752     History of Changes
Other Study ID Numbers: CA182-037, EUDRACT # 2008-008715-26
Study First Received: May 22, 2009
Last Updated: June 18, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
China: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hong Kong: Department of Health
Italy: Istituto Superiore de Sanita (ISS)
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Taiwan: Department of Health
Thailand: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
HCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on May 16, 2013